Cleared Traditional

CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)

K901229 · Technicon Instruments Corp. · Chemistry
May 1990
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K901229 is an FDA 510(k) clearance for the CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE), a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on May 4, 1990, 51 days after receiving the submission on March 14, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K901229 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 1990
Decision Date May 04, 1990
Days to Decision 51 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CGX — Alkaline Picrate, Colorimetry, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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